AS9100D

AS9100DBureauVeritasCertificationChina中文译稿Page1of51data:10/2016Qualitymanagementsystems—RequirementsforAviation,Space,andDefenseOrganizationsRATIONALEThisstandardhasbeenrevisedtoincorporatethenewclausestructureandcontentofISO9001:2015.Inaddition,industryrequirements,definitions,andnoteshavebeenrevisedinresponsetobothISO9001revisionsandstakeholderneeds.FOREWORDToassurecustomersatisfaction,aviation,space,anddefenseorganizationsmustprovide,andcontinuallyimprove,safeandreliableproductsandservicesthatmeetorexceedcustomerandapplicablestatutoryandregulatoryrequirements.Theglobalizationoftheindustryandtheresultingdiversityofregionalandnationalrequirementsandexpectationshavecomplicatedthisobjective.Organizationshavethechallengeofpurchasingproductsandservicesfromexternalprovidersthroughouttheworldandatalllevelsofthesupplychain.Externalprovidershavethechallengeofdeliveringproductsandservicestomultiplecustomershavingvaryingqualityrequirementsandexpectations.IndustryhasestablishedtheInternationalAerospaceQualityGroup(IAQG.,withrepresentativesfromaviation,space,anddefensecompaniesintheAmericas,Asia/Pacific,andEurope,toimplementinitiativesthatmakesignificantimprovementsinqualityandreductionsincostthroughoutthevaluestream.ThisstandardhasbeenpreparedbytheIAQG.Thisdocumentstandardizesqualitymanagementsystemrequirementstothegreatestextentpossibleandcanbeusedatalllevelsofthesupplychainbyorganizationsaroundtheworld.Itsuseshouldresultinimprovedquality,cost,anddeliveryperformancethroughthereductionoreliminationoforganization-uniquerequirements,effectiveimplementationofthequalitymanagementsystem,andwiderapplicationofgoodpractice.Whileprimarilydevelopedfortheaviation,space,anddefenseindustry,thisstandardcanalsobeusedinotherindustrysectorswhenaqualitymanagementsystemwithadditionalrequirementsoveranISO9001systemisneeded.ThisstandardincludesISO9001:20151qualitymanagementsystemrequirementsandspecifiesadditionalaviation,space,anddefenseindustryrequirements,definitions,andnotesasshowninbold,italictext.INTENDEDAPPLICATIONThisstandardisintendedforusebyorganizationsthatdesign,develop,orprovideaviation,space,anddefenseproductsandservices;andbyorganizationsprovidingpost-deliveryactivities,includingtheprovisionofmaintenance,spareparts,质量管理体系–对于航空、航天以及国防组织的要求理论基础本标准已经根据ISO9001:2015的新条款结构及内容进行了修订。此外，应ISO9001修订及相关利益方的需求，行业要求、定义及注释也做了相应修订。前言为了确保客户满意，航空、航天和国防组织必须提供并持续改进安全及可靠的产品和服务，以满足并超越客户和适用的法律法规要求。该行业的全球化，各区域及各国要求和期望的多样性，使这个目标更为复杂。从世界及供应链的各级外部供方处采购产品和服务，对于组织来说是一项挑战。向具有不同质量要求和期望的各类客户交付产品和服务，对外部供方来说也是一项挑战。行业建立了国际航空质量组织（IAQG.，代表来自美国、亚太和欧洲的航空、航天及国防的公司，来推进质量方面的重大改进和整个价值流中成本降低。本标准由IAQG编制。本文尽最大可能使质量管理体系要求标准化，以适用于全世界组织的供应链上的各级公司。通过减少或者消除组织的特殊要求，质量管理体系的有效执行，以及良好实践的广泛应用，本标准的应用可以带来质量、成本和交付表现上的改进。尽管主要是为航空、航天和国防行业开发的，当需要超越ISO9001之上的要求的质量管理体系时，本标准也可应用于其他工业部门。本标准包含了IOS9001:2015质量管理体系要求，并规定了航空、航天和国防行业的附加要求、定义和注释，该内容以粗斜体字表示。预期应用本标准适用于设计、开发、或提供航空、航天和国防产品和服务，以及提供售后服务的组织，包括给自己的产品提供维修，备件，或材料的组织。AS9100DBureauVeritasCertificationChina中文译稿Page2of51data:10/2016ormaterialsfortheirownproductsandservices.NOTE:Organizationswhoseproductsaredeliverablesoftware,orcontaindeliverablesoftware,shouldusetheIAQG-developed9115standard(seeBibliography)whenplanningandevaluatingthesoftwaredesign,development,ormanagementactivitiesoftheorganization.The9115standardprovidesguidancetotherequirementsofthe9100standardwhenitisdesiredtoadd“software”tothe9100qualitymanagementsystemscope.Organizationswhoseprimarybusinessisprovidingmaintenanceorcontinuingairworthinessmanagementservicesforcivilormilitaryaviationarticlesandproducts;andoriginalequipmentmanufacturerswithmaintenance,repair,andoverhauloperationsthatareoperatedautonomously,orthataresubstantiallydifferentfromtheirproductionoperations;shouldusetheIAQG-developed9110standard(seeBibliography).Organizationsthatprocureparts,materials,andassembliesandresellstheseproductstoacustomerintheaviation,space,anddefenseindustryshouldusetheIAQG-developed9120standard(seeBibliography).Thisincludesorganizationsthatprocureproductsandsplitthemintosmallerquantities,aswellasthosethatcoordinateacustomerorregulatorycontrolledprocessontheproduct.INTRODUCTION0.1GeneralTheadoptionofaqualitymanagementsystemisastrategicdecisionforanorganizationthatcanhelptoimproveitsoverallperformanceandprovideasoundbasisforsustainabledevelopmentinitiatives.ThepotentialbenefitstoanorganizationofimplementingaqualitymanagementsystembasedonthisInternationalStandardare:a.theabilitytoconsistentlyprovideproductsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirements;b.facilitatingopportunitiestoenhancecustomersatisfaction;c.addressingrisksandopportunitiesassociatedwithitscontextandobjectives;d.theabilitytodemonstrateconformitytospecifiedqualitymanagementsystemrequirements.ThisInternationalStandardcanbeusedbyinternalandexternalparties.ItisnottheintentofthisInternationalStandardtoimplytheneedfor:注：产品是交付软件，或包含交付软件的组织在策划和评估组织的软件设计、开发或者管理活动时，应当使用IAQG开发的9115标准（见参考目录）。9115标准在希望在9100质量管理体系范围内增加“软件”时提供了针对9100标准要求的指南。主要业务是给民用和军用航空项目和产品提供维修或者持续适航管理服务的组织;以及独立地进行维护，修理和大修操作，或者明显不同于他们自己的生产